Article | March 25, 2019

The Top 5 Questions To Ask When Developing A REMS

By Natalie O’Donnell, Executive Director, Safety, Epidemiology, Registries & Risk Management, UBC

Risk_450x300.jpg

A REMS should be considered when risk mitigation efforts are required beyond product labeling and routine pharmacovigilance. This article answers the following questions regarding REMS

  • How do you determine if a REMS is needed during product development?
  • Who from your organization needs to be at the REMS design table?
  • How do you align the products commercial strategy with the REMS?
  • What are the appropriate metrics to assess your REMS?
  • Can you implement a REMS in your organization or should you plan to outsource?

VIEW THE ARTICLE!
Signing up provides unlimited access to:
Signing up provides unlimited access to:
  • Trend and Leadership Articles
  • Case Studies
  • Extensive Product Database
  • Premium Content
HELLO. PLEASE LOG IN. X

Not yet a member of Clinical Leader? Register today.

ACCOUNT SIGN UP X
Please fill in your account details
Login Information
I'm interested in newsletter subscriptions.
ACCOUNT SIGN UP

Subscriptions

Sign up for the newsletter that brings you the industry's latest news, technologies, trends and products.

You might also want to: